Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

NCT ID: NCT05685641

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-09-30

Brief Summary

In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.

Conditions

Acquired Immunodeficiency Syndrome; Histoplasmosis AIDS; Tuberculosis Infection; Cryptococcal Meningitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention group

All enrolled patients will be included in this arm of the study, patients will be administered all rapid diagnostic tests as part of their diagnostic work-up (this will constitute the main intervention of the study)

Group Type: EXPERIMENTAL

Histoplasma Urine Antigen Lateral Flow Antigen test

Intervention Type: DIAGNOSTIC_TEST

Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease

Cryptococcal Lateral Flow Antigen test

Intervention Type: DIAGNOSTIC_TEST

Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease

Tuberculosis-lipoarabinomannan Lateral Flow Antigen test

Intervention Type: DIAGNOSTIC_TEST

Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease

Interventions

Histoplasma Urine Antigen Lateral Flow Antigen test

Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease

Intervention Type: DIAGNOSTIC_TEST

Cryptococcal Lateral Flow Antigen test

Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease

Intervention Type: DIAGNOSTIC_TEST

Tuberculosis-lipoarabinomannan Lateral Flow Antigen test

Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Positive ELISA test or positive viral load for HIV.
• Patients with suspected or confirmed advanced HIV disease defined as follows:

• Confirmed: asymptomatic patients with CD4 count less than 200 cells/ml within 3 months of study inclusion or confirmed diagnosis of an AIDS-defining opportunistic illness within the last 3 months.
• Suspected: patients who, irrespective of CD4 count, present any symptoms suggestive of systemic infection that, at the discretion of the treating physicians, produce suspicion of an AIDS-defining opportunistic disease (e.g., fever, productive cough, diaphragmatic diapers, etc.). Fever, productive cough, nocturnal diaphoresis, altered mental status, headache, lymphadenopathy, dermatological lesions) or that meet criteria for HIV wasting syndrome (loss of 10% of baseline weight plus the presence of chronic diarrhea or chronic weakness and an episode of fever in the last 30 days).
• Patients without effective antiretroviral therapy defined as not having received antiretroviral treatment in the last 3 months or in virologic failure (2 consecutive viral loads with more than 1000 copies/ml).

Exclusion Criteria

• Patients with a viral load of less than 1000 copies/ml.
• Patients presenting for care having started treatment for systemic mycoses (amphotericin B or azoles) and tuberculosis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cancerology

OTHER_GOV

Sponsor Role: collaborator

Hospital General Dr. Manuel Gea González

OTHER_GOV

Sponsor Role: collaborator

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role: collaborator

National Institute of Respiratory Diseases, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Camiro Zúñiga, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Medico ABC

Locations

General Hospital Dr. Manuel Gea Gonzalez

Mexico City, , Mexico

National Center of Nutrition and Medical Sciences

Mexico City, , Mexico

National Institute of Cancerology

Mexico City, , Mexico

National Institute of Respiratory Diseases

Mexico City, , Mexico

Countries

Mexico

Central Contacts

Victor Ahumada Topete, MD

Role: CONTACT

victor.ahumada@uehi.mx

55 5487 1700

Facility Contacts

Ana Patricia Rodríguez Zulueta, MD

Role: primary

rozu76@gmail.com

55 4000 3000

Álvaro López Iñiguez, MD

Role: primary

alvarolopez@revistamedicamd.com

55 5487 0900

Alexandra Martin Onraet, MD

Role: primary

alexitemaon@gmail.com

55 5628 0400

Victor Ahumada Topete, MD

Role: primary

victor.ahumada@uehi.mx

55 5487 1700

Other Identifiers

181250

Identifier Type: -

Identifier Source: org_study_id